The present invention relates generally to the use of respiration or ventilation masks and, more specifically, to interfacial seal assemblies configured to be disposed between a respiration mask and the facial features of a wearer in a manner that reduces leakage associated with the area or interface between a perimeter edge of a mask and the anatomy or physical structure of the wearer and reduces agitation of the dermis or respiration flow passages such as the nasal mucosa during non-intubation positive pressure respiration assistance.
Respiration masks have various uses or applications in various arts including various medical and industrials fields. In the medical arts, respiration or ventilation masks can be used in resuscitation, sleep apnea devices, respiration monitoring, anesthesia, etc. Various industrial environments, particularly those where airborne particulate or chemicals are present, also commonly require utilization of respiration masks. It is appreciated that the performance of such respiration masks depends largely on the ability to limit, regulate and/or control exposure or communication between the respiration path and atmosphere.
One aspect related to the performance of such systems is the ability to provide a substantially or entirely sealed interface between the perimeter edge of the mask and the adjacent anatomy or features of the wearer. Although some applications require a fairly robust sealed cooperation, such as firefighting and working in environments with dangerous chemicals or particulates, other applications allow for a degree of sealed cooperation that is less than absolute. Sleep apnea is one such application wherein an absolute sealed interaction is not absolutely necessary but wherein the desired performance of the apnea device can be detrimentally affected by insufficient degrees of sealed interaction between the mask and the anatomy or features of the wearer.
The degree of facial hair a wearer prefers to display must also be considered in many respiration mask applications. Although some mask configurations and applications will tolerate a small degree of facial hair, increased amounts and lengths of facial hair can detract from the sealed interaction between the mask and the wearer. In anesthesia and sleep apnea applications, such facial hair is commonly not tolerated during utilization of the underlying device as too much of the respiration flow escapes the respiration path and thereby the patient or wearer via an unacceptable or poor degree of “sealed” cooperation of the mask with the anatomy of the wearer.
Reduced or abnormal facial structure can also detract from the ability to generate a desired degree of sealed interaction between the respiration or ventilation mask and the underlying patient or wearer. For instance, reduced dontia, mandible, or other dental or anatomical anomalies can result in ill-suited or undesirable cooperation of a conventional generally somewhat conically shaped respiration masks with the mouth and nasal area of a wearer in a manner that generates a desired degree of sealed interaction of the respiration mask with the wearer.
Prolonged periods of exposure to the respiration gases or interaction with respiration mask appliances can also present undesired consequences associated with the extended use of respiration masks. Endotracheal intubation is considered inappropriate in many applications such as where a user suffers from an obstructive airway or other airflow limitation, acute respiratory failure or distress system, obesity hypoventilation syndrome, cardiogenic pulmonary edema, onset respiratory failure during perioperative periods, those patients that experience difficulty weaning from invasive mechanical ventilator support, etc. Appropriate or desired noninvasive ventilator assistance allows many patients to avoid the discomfort and risk of injury or infection associated with invasion ventilation, such as intubation.
Obstructive sleep apnea (OSA) is a common type of sleep apnea and is caused by obstruction of the upper airway. OSA is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is usually associated with a reduction in blood oxygen saturation. These pauses in breathing, called “apneas” (literally, “without breath”), typically last 20 to 40 seconds.
Individuals suffering from OSA are rarely aware of having difficulty breathing, even upon awakening. It is recognized as a problem by others witnessing the individual during episodes or is suspected because of its effects on the body and/or conditions that is a consequence of a previous disease or injury (sequelae). OSA is commonly accompanied with snoring. Some use the term “obstructive sleep apnea syndrome” to refer to OSA which is associated with symptoms during the daytime. Symptoms may be present for years or even decades without identification, during which time the individual may become conditioned to the daytime sleepiness and fatigue associated with significant levels of sleep disturbance. Individuals who generally sleep alone are often unaware of the condition, without a regular bed-partner to notice and make them aware of their symptoms. If left unaddressed, these individuals can eventually suffer from non-reversible heart damage, increased blood pressure, and even stroke.
As the muscle tone of the body ordinarily relaxes during sleep, and the airway at the throat is composed of walls of soft tissue, which can collapse, it is not surprising that breathing can be obstructed during sleep. Although a very minor degree of OSA is considered to be within the bounds of normal sleep, many individuals can experience episodes of OSA at some point in life and a small percentage of people may suffer from chronic or severe OSA.
Continuous positive airway pressure (CPAP) is a treatment that uses mild air pressure to keep the airways open. CPAP typically is used by people who have breathing problems, such as sleep apnea. It can be difficult to maintain a desired degree of sealed interaction between the respiration or ventilation mask and the respiration path of wearer's or patients having various features including excessive or aggressive facial hair, anatomical facial anomalies, obese patients, and/or adentuless patients.
When preparing for the administration of anesthesia, an oxygen, respiration, or ventilation mask is placed on the patient's face to assure adequate or desired oxygenation. Maintaining a desired seal between the mask and the face of the patient will largely contribute to the degree of oxygenation communicated to a patient.
An anesthesia provider's maintenance of a patient airway largely affects the anesthesia process. Prior to induction of general anesthesia (procedure to produce loss of consciousness), patients are routinely pre oxygenated. This is accomplished by providing oxygen to the patient at a high flow rate through a tight fitting mask placed over the nose and/or mouth. This is usually done for several minutes. During induction, a patient is rendered unconscious with loss of protective airway reflexes and loss of breathing due to administered medications. It is during this time that the sealed interaction between the patients face and the mask by the anesthesia provider allows the desired and monitored ventilation of the patient. The presence of facial hair or other unusual facial anatomy detracts from the ability to obtain the desired adequate seal for oxygenation.
When a desired sealed interface is not achieved, the level of oxygen in the patient's blood drops as the oxygen escapes the respiration path at the interface between the mask and the patient. If unaddressed, such drops puts patient at risk of a cardiac event and may even lead to hypoxic injury. Patients with facial hair and unusual facial anatomy make it very difficult to achieve an adequate seal. Currently, when an airway problem exists as patients are anesthetized due to poor mask seal, extra personnel are employed and/or a variety of taping implemented to cover the face to achieve a desired tight, secure seal.
Currently, positive pressure noninvasive ventilation requires either both the hands of a single technician or multiple technicians responsible for maintain an adequate sealed interface between the mask and the patient and operation of the devices associated with generating the positive pressure respiration flows. Inadequate attention to the desired operation of the ventilation system and patient interface can result in poor patient oxygenation and the risks inherent thereto. It should be appreciated that such risks and the detriments associated therewith increase when inadequate attention is provided to the ventilation system associated with sedated patients in the hospital settings such as in the operating room, intensive care unit or patients that are otherwise incapable of providing an indication as to the poor oxygenation.
Recent years have shown an increase in patients diagnosed with obstructive sleep apnea (OSA). Treatment requires continuous positive airway pressure (CPAP) ventilation as they sleep. This is accomplished by a machine and delivered to the patient by mask. As positive pressure is applied, it keeps patients airway open and allows them to get a good night sleep without snoring or breath holding. If the patient has facial hair or facial anomalies they are not able to achieve an adequate seal resulting in the perception that that the CPAP machine is not helping or otherwise operating improperly. Such a perception leads many users to be considered noncompliant with prescribed treatments. Snoring and breath holding increases pressure in the vessels of the lungs and can lead to increased, pressure and ultimately enlargement of the heart. Not using CPAP, when prescribed, places patients at risks of developing heart conditions caused by obstruction of the airway and periods of not breathing (apnea). As a result these patients suffer lethargy during the day, reduced exercise tolerance, enlarged heart leading to reduced percentage of heart muscle function, and weight gain.
Currently ventilation or respiration masks commonly include a plastic cushion or pillow that rests upon the skin of the user. If a small leak develops in such mask systems, the pressure drops. The contact between the cushion or pillow and the skin of the user as well as the leakage is commonly detrimental to the patient and can lead to sores, skin ulcers that are very difficult to heal when repetitive pressure is applied to the affected skin, eruptions, and dry eye conditions if the leak is directed toward the ocular anatomy of the wearer. Also if a leak is present, the auto-adjusting CPAP machines increase the pressure to keep the airway open which can lead to gastric distention and painful abdominal bloating, belching, and increase in gastroesophageal reflux leading to discontinuation of the use of the CPAP.
Currently, patients undergoing eye surgery also have to discontinue the use of the CPAP as any small leak could lead to conjunctivitis and/or infection of the eye.
Management of the respiratory distress in neonates and infants is also extremely important to their survival. CPAP is considered a simple and effective therapy for respiratory distress of the neonates. The correct application of CPAP can decrease the work of breathing, prevent airway collapse, and reduce oxygen requirements as high oxygen concentration can be detrimental to addressing the health concerns of infants undergoing such treatment.
Therefore, there is a need for a seal device and methods of improving respiration assistance and ventilation practices that provides a generally, but not necessarily absolute, sealed interaction between the perimeter edge of the mask and anatomy or features of wearers having various facial features including facial hair as well as other anatomical abnormalities or unique structures. There is also a need for a ventilation/respiration assistance device that mitigates the detrimental consequences associated with extended periods of ventilation or exposure of the epidermis of the user to the respiration flow and/or interaction with the perimeter edge of masks associated with such activities.